ivdtools - Statistical Tools for Evaluation of in Vitro Diagnostic Reagents

Provides statistical workflows used in the evaluation of in vitro diagnostic reagents. Facilities include method comparison, commutability assessment, Bland-Altman and receiver operating characteristic analysis, qualitative agreement, C5 and C95 estimation, precision and variance-component analysis, linearity, interference, dilution and spiking studies, high-dose hook assessment, measurement uncertainty, reference-material bias, reference intervals, stability studies, quality-control charts, curve fitting, analytical sensitivity, outlier and normality assessment, and sample-size calculations. For methodological details, see Bland and Altman (1986) <doi:10.1016/S0140-6736(86)90837-8>, Passing and Bablok (1983) <doi:10.1515/cclm.1983.21.11.709>, Linnet (1993) <doi:10.1093/clinchem/39.3.424>, Hawkins and Kraker (2026) <doi:10.1093/jalm/jfaf183>, Hanley and McNeil (1982) <doi:10.1148/radiology.143.1.7063747>, Horn et al. (1998) <doi:10.1093/clinchem/44.3.622>, Westgard et al. (1981) <doi:10.1093/clinchem/27.3.493>, and Lu et al. (2016) <doi:10.1515/ijb-2015-0039>.